Human Research Protections
News Brief
FALL 2011
Revision to UC Irvine’s Human Research Education Program
Inside this issue:
Changes to
Human
1
Research
Education: CITI
As part of our efforts to promote the highest ethical standards in the conduct of
research, UCI is revising the education requirements for investigators who engage
in research involving human subjects. The new education requirement applies to all
faculty, staff, and students who serve as lead researchers, co-researchers, research
personnel or faculty sponsors at UCI.
 UCI’s Human Research Protections unit in the Office of Research is adopting the
Collaborative Institutional Training Initiative (CITI) modules as our new
web-based human research protections education program.
Two Basic Human Research Training courses are offered, one for Biomedical
Investigators and one for Social & Behavioral Investigators. Individuals choose
the course that best matches their research activities.
It’s Official!
AAHRPP
2
Re-accreditation
 Investigators are now required to complete a CITI refresher course every five
years in order to conduct research involving human subjects. There are two
Refresher Human Research Training courses, a biomedical version and a social &
behavioral version. Again, individuals choose the course that best matches their
research activities.
The CITI program is available at https://www.citiprogram.org/default.asp.
When do these new changes take effect?
Changes to
Other Committee
2
Reviews
Attention
Student
3
Researchers!
Effective October 15, 2011 individuals who have not previously completed the
UCI Human Research Tutorial are required to complete either the CITI Basic Human
Research Training course for Biomedical Investigators or for Social & Behavioral
Investigators before they can be listed on a new IRB Application or added to an
active, ongoing IRB-approved study.
Effective January 15, 2012 individuals who completed the Human Research
Tutorial more than five years ago are required to complete either the CITI Refresher
course for Biomedical Investigators or for Social & Behavioral Investigators before
they can be listed on a new IRB submission or added to an active, ongoing IRBapproved study. Failure to complete a CITI Refresher course may delay review and
approval of modification requests, continuing review applications, and new IRB
Applications.
NOTE: Completing the existing Human Research Tutorial again is not
sufficient to meet this requirement.
You can review when you last completed the Human Research Tutorial at http://
apps.research.uci.edu/tutorialcheck/. Individuals who completed the Human
Research tutorial more than five years ago will also be sent courtesy reminder
notices.
HRP Staff
Contact
Information
AND
Education &
Reminders
4
A Frequently Asked Questions web page has been developed to provide individuals
with further details about the CITI courses.
If there are additional questions regarding the new policy or the CITI courses,
please contact the Human Research Protections staff.
Page 1
Page 2
FULL AAHRPP ACCREDITATION RECEIVED!
The Association for Accreditation of Human Research Protection
Programs, Inc. (AAHRPP) has confirmed that UCI’s Human Research
Protection Program has received full AAHRPP accreditation for five
years!!!
Thank you for your involvement and support!!
CHANGES TO OTHER COMMITTEE REVIEWS
COIOC
EFFECTIVE IMMEDIATELY there are changes to the Conflict of Interest Oversight Committee
(COIOC) and the Institutional Review Board (IRB) review process.
NEW STUDIES: In order to facilitate the review process, for new studies only, IRB review may run
concurrent with COIOC review. A new study will not be granted a conditional approval however
until the IRB has reviewed the COIOC report and suggested language for the consent form as
accepted by the Associate Vice Chancellor for Research. If this report is not available at the time of
IRB review, the study will be tabled pending receipt of the COIOC report, documenting the COIOC
recommendations. Once the COIOC report is received, the study (along with the COIOC report) will
be re-presented to the IRB for review. The IRB has final authority to determine whether the
management plan related to the disclosable financial interest is sufficient to prevent financial
interests from adversely affecting the rights and welfare of human research subjects.
MODIFICATIONS (e-MODs) AND CONTINUING PROTOCOL APPLICATIONS (e-CPAs): For
e-MODs and e-CPAs, IRB review will continue to be on hold pending COIOC review and acceptance
of the COIOC recommendations by the Associate Vice Chancellor for Research. This process
continues to be the most facilitative for researchers. The IRB has final authority to determine
whether the management plan related to the disclosable financial interest is sufficient to prevent
financial interests from adversely affecting the rights and welfare of human research subjects.
To ensure that IRB submissions are reviewed in a timely manner, it is strongly recommended that
Lead Researchers (when reporting disclosable financial interests for themselves or other research
personnel) submit their IRB documentation including the COI disclosure information to the Office of
Research Administration by the COIOC deadline. COIOC and IRB deadlines are posted on the ORA
Calendar.
RSC
EFFECTIVE OCTOBER 1, 2011 you will note changes to the Radiation and Safety Committee as it
relates to the IRB review process.
NEW STUDIES AND e-MODs: New IRB applications that include research procedures involving
radioactive materials or radiation-producing machines and modification requests that add research
procedures involving radiation must obtain Radiation Safety Committee (RSC) approval before IRB
review. The IRB will review the results of the RSC before granting approval.
For more information on this topic, as well as important reminders about other required
committees, visit the HRP website and refer to the subsection titled, “Other Required UCI Reviews”.
FALL 2011
Additional Resource: http://www.research.uci.edu/ora/hrpp/studentresearchers.htm
Page 3
ATTENTION STUDENT RESEARCHERS!
Does Your Project Require Prospective IRB Approval?
The UCI Institutional Review Board (IRB) is a committee of scientists and non-scientists, responsible
for the prospective review and approval of all human subject research at UCI. This includes all
interventions and interactions with human subjects for research, including advertising, recruitment
and/or screening of potential subjects.
Example:
An undergraduate psychology major decides to investigate students’ perspectives
on their own ethnic and gender identity. The student hopes to present her findings
at the Undergraduate Research Opportunities Program (UROP) and possibly have a
publication to list on her application to graduate school. The undergraduate
investigator designs an experiment. She posts recruitment flyers around campus,
conducts face to face interviews with about 20 student volunteers, analyzes the
data, and writes a summary.
This activity constitutes human subjects research. The student is conducting a systematic
investigation (e.g., interviews), designed to contribute to generalizable knowledge (e.g.,
presenting at UROP, possible future publications). The student will obtain data through
communication and interaction with human subjects (e.g., interviews) for research purposes.
Prior IRB review and approval is required.
The UCI IRB prospectively reviews all study materials, including recruitment flyers, informed
consent documents including consent scripts, online web surveys, interview questions, and
questionnaires. All members of the study team who are conducting human subject research must
be listed on the UCI IRB approved version of the Protocol Narrative, PRIOR to engaging in human
subject research.
What Types of Approval does the IRB Issue?
 Exempt registration is granted if a study meets one of the six exempt categories. Exempt
research involves the lowest level of risk to subjects (e.g., anonymous survey).
 Expedited approval is generally granted if a study involves no more than minimal risk to subjects
and meets one of the seven expedited categories of research for new studies (i.e. face-to-face
interviews, studies involving auditory or visual stimuli).
How Long Does IRB Approval Last?
Human research studies granted Exempt registration are registered for 3 years. Human research
studies granted Expedited approval require at least annual IRB review.
To continue an Expedited research project, an application for continuing review must be submitted
to the UCI IRB in advance of the study expiration. If a researcher fails to submit an electronic
Continuing Protocol Application (e-CPA) to the IRB or the IRB does not approve continuation of the
research before the date of expiration, the research, including all research activities must stop.
On Line Resources:
For more information, including examples of educational activities that do not involve Human
Subject Research, please see the definition of human subjects research.
For more information about the continuing review process, please review the following page:
http://www.research.uci.edu/ora/hrpp/continuingprotocolapproval.htm
We also encourage you to contact the HRP Staff if you have questions.
FALL 2011
Page 4
HRP Staff Contact Information
Institutional Review Board “A”
IRB Team “D”
Biomedical
Biomedical
Education & Reminders:
Tips from HRP Staff
Expedited and Exempt Submissions
Matt Kinder, CIP
Administrator
949-824-9819
mkinder@uci.edu
Mihaela Nistor
Senior Analyst
949-824-3711
Joy Chu
Analyst
949-824-6068
—————————————————
Institutional Review Board “B”
Biomedical
Valerie Sanchez, MA, CCRP
Administrator
949-824-7109
Jessica Sheldon, CIP
949-824-3831
jessica.sheldon@uci.edu
Kaycie Craib
Senior Analyst
949-824-5057
kcraib@uci.edu
OPEN POSITION
Analyst
—————————————————
Karen Allen, MA, CIP
Director
Human Research Protections
949-824-1558
karen.allen@uci.edu
valerie.ms@uci.edu
Beverley Esparza, CIP
Cheree DuBose, CIP
Human Research Protections
Assistant Director
Senior Analyst
949-824-5746
949-824-5622
besparza@uci.edu
cheree.dubose@rgs.uci.edu
Theresa Sanchez, CIP
Analyst
949-824-2125
DRUG LOGS
Administrator
Debbie Melamud, MPH
Administrator
Human Research Protections
debbie.melamud@uci.edu
HRP Staff Member Valerie
Sanchez wants to remind
the research community to
submit their Drug Logs when
the research project involves
investigational drugs.
WHY?
Research involving the use
of investigational test
articles (i.e., investigational
drugs, biologics or devices)
requires that the
Investigator or other
appropriate individual or
entity (e.g., hospital
pharmacy), provide
appropriate control of test
articles.
The Drug Log meets this
requirement for
documentation purposes and
is required if the study
includes an investigational
drug or biologic.
tmsanche@uci.edu
——————————————————
Institutional Review Board “C”
Social - Behavioral
Human Research
Protections
U.S. Mail:
Office of Research
Christine Hegel-Cantarella, PhD
University of California, Irvine
Administrator
5171 California Ave., Suite 150
949-824-4779
Irvine, CA 92697-7600
Alicia Asgari
The Office is Open:
Senior Analyst
Monday—Friday
949-824-7114
8am—5pm
alicia.asgari@uci.edu
OPEN POSITION
Analyst
General Email:
IRB@research.uci.edu
We’re on the Web!:
http://www.research.uci.edu/ora/
SAMPLE: Drug/Biologic
Accountability Log
For more information on this
topic, as well as important
reminders related to the use
of
investigational
devices, visit
the HRP
Website and
refer to the
subsection
titled, “Drugs,
Biologics and
Devices”.
hrpp/index.htm
FALL 2011